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EP4467984A3 - Fibrosis biomarker assay - Google Patents

Fibrosis biomarker assay Download PDF

Info

Publication number
EP4467984A3
EP4467984A3 EP24200645.0A EP24200645A EP4467984A3 EP 4467984 A3 EP4467984 A3 EP 4467984A3 EP 24200645 A EP24200645 A EP 24200645A EP 4467984 A3 EP4467984 A3 EP 4467984A3
Authority
EP
European Patent Office
Prior art keywords
collagen type
protein
neo
measure
fibrosis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24200645.0A
Other languages
German (de)
French (fr)
Other versions
EP4467984A2 (en
Inventor
Sanne VEIDAL
Morten Karsdal
Diana Julie Leeming
Natasha BARASCUK MICHAELSEN
Helene Skjot-Arkil
Antonio Segovia-Silvestre
Efstathios Vassiliadis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
Nordic Bioscience AS
Original Assignee
Novartis AG
Nordic Bioscience AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novartis AG, Nordic Bioscience AS filed Critical Novartis AG
Publication of EP4467984A2 publication Critical patent/EP4467984A2/en
Publication of EP4467984A3 publication Critical patent/EP4467984A3/en
Pending legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • C12Q1/37—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving peptidase or proteinase
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4737—C-reactive protein
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/78—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/08—Hepato-biliairy disorders other than hepatitis
    • G01N2800/085—Liver diseases, e.g. portal hypertension, fibrosis, cirrhosis, bilirubin
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/32—Cardiovascular disorders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/50—Determining the risk of developing a disease

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Peptides Or Proteins (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Methods of diagnosis or of quantitation of fibrosis comprising conducting an immunoassay to measure neo-epitope containing protein fragments naturally present in a bioflui sample, and associating an elevation of said measure in said patient above a normal level with the presence or extent of fibrosis. The immunoassay is conducted by a method comprising:contacting protein fragments naturally present in said sample with an immunological binding partner reactive with a neo-epitope formed by cleavage of a protein by a proteinase and measuring the extent of binding of peptide fragments to said immunological binding partner to measure therein protein fragments comprising said neo-epitope, and wherein said protein is collagen type III, collagen type I, collagen type IV, collagen type V, or collagen type VI, elastin, biglycan, decorin, lumican, versican, perlecan, neurocan, brevican, fibromodulin, serglycin, syndecan, betaglycan, vimentin, or C-reactive protein.
EP24200645.0A 2009-03-30 2010-03-29 Fibrosis biomarker assay Pending EP4467984A3 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US21146709P 2009-03-30 2009-03-30
US28908109P 2009-12-22 2009-12-22
EP19174151.1A EP3578664B1 (en) 2009-03-30 2010-03-29 Collagen iv neo-epitope fibrosis assay
EP16205956.2A EP3173792B1 (en) 2009-03-30 2010-03-29 Crp neo-epitope fibrosis assay
EP10715752.1A EP2414844B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay
EP14169636.9A EP2770327B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay
PCT/EP2010/054096 WO2010115749A2 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay

Related Parent Applications (5)

Application Number Title Priority Date Filing Date
EP16205956.2A Division EP3173792B1 (en) 2009-03-30 2010-03-29 Crp neo-epitope fibrosis assay
EP19174151.1A Division EP3578664B1 (en) 2009-03-30 2010-03-29 Collagen iv neo-epitope fibrosis assay
EP19174151.1A Division-Into EP3578664B1 (en) 2009-03-30 2010-03-29 Collagen iv neo-epitope fibrosis assay
EP10715752.1A Division EP2414844B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay
EP14169636.9A Division EP2770327B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay

Publications (2)

Publication Number Publication Date
EP4467984A2 EP4467984A2 (en) 2024-11-27
EP4467984A3 true EP4467984A3 (en) 2024-12-04

Family

ID=42199024

Family Applications (5)

Application Number Title Priority Date Filing Date
EP19174151.1A Active EP3578664B1 (en) 2009-03-30 2010-03-29 Collagen iv neo-epitope fibrosis assay
EP10715752.1A Active EP2414844B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay
EP16205956.2A Active EP3173792B1 (en) 2009-03-30 2010-03-29 Crp neo-epitope fibrosis assay
EP14169636.9A Active EP2770327B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay
EP24200645.0A Pending EP4467984A3 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay

Family Applications Before (4)

Application Number Title Priority Date Filing Date
EP19174151.1A Active EP3578664B1 (en) 2009-03-30 2010-03-29 Collagen iv neo-epitope fibrosis assay
EP10715752.1A Active EP2414844B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay
EP16205956.2A Active EP3173792B1 (en) 2009-03-30 2010-03-29 Crp neo-epitope fibrosis assay
EP14169636.9A Active EP2770327B1 (en) 2009-03-30 2010-03-29 Fibrosis biomarker assay

Country Status (8)

Country Link
US (3) US9206464B2 (en)
EP (5) EP3578664B1 (en)
JP (2) JP5978128B2 (en)
KR (1) KR101700463B1 (en)
CN (1) CN103238071B (en)
DK (3) DK3173792T3 (en)
ES (2) ES2635494T3 (en)
WO (1) WO2010115749A2 (en)

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Also Published As

Publication number Publication date
ES2529101T3 (en) 2015-02-16
CN103238071B (en) 2016-07-06
US9880177B2 (en) 2018-01-30
EP3578664C0 (en) 2024-10-30
JP5978128B2 (en) 2016-08-24
EP2414844B1 (en) 2014-12-10
ES2635494T3 (en) 2017-10-04
JP6095702B2 (en) 2017-03-15
WO2010115749A3 (en) 2011-01-13
US20170176458A1 (en) 2017-06-22
US20100209940A1 (en) 2010-08-19
EP3173792A3 (en) 2017-07-05
JP2015108635A (en) 2015-06-11
EP3173792A2 (en) 2017-05-31
KR20110137823A (en) 2011-12-23
JP2012522233A (en) 2012-09-20
EP3173792B1 (en) 2019-06-12
EP2414844A2 (en) 2012-02-08
EP3578664B1 (en) 2024-10-30
EP4467984A2 (en) 2024-11-27
US20160091502A1 (en) 2016-03-31
US9606130B2 (en) 2017-03-28
DK2414844T3 (en) 2015-03-02
EP2770327B1 (en) 2017-06-14
EP2770327A1 (en) 2014-08-27
US9206464B2 (en) 2015-12-08
DK2770327T3 (en) 2017-08-28
KR101700463B1 (en) 2017-01-26
DK3173792T3 (en) 2019-08-05
EP3578664A1 (en) 2019-12-11
CN103238071A (en) 2013-08-07
WO2010115749A2 (en) 2010-10-14

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